Manager, Regulatory Affairs, Hybrid

MTF

Edison, NJ · HybridFull-time$125K/yrSeen 4mo agoSeen in employer's feed 4 days ago

Edison, NJHybridFull-time$125K/yrSeen 4mo agoSeen in employer's feed 4 days ago

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At a glance

Compensation

$125K/yr

Location

Edison, NJHybrid

Schedule

Full-time

Work Authorization

Not specified

Olive lists jobs from US employers, including remote roles you can work from the United States.

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Manager, Regulatory Affairs leads day-to-day operations of the Regulatory Affairs function, overseeing staff and ensuring effective execution of U.S. and international regulatory activities such as submissions, inspections, audits, recalls, licensing, labeling, quality documentation, risk management, and design control support, with up to 20% travel to MTF locations and suppliers.

Skills & qualifications

RequiredNice to have

Skills

FDA RegulationsQSRcGMPISO 9001ISO 13485CE MarkingRegulatory SubmissionsInspections and AuditsRisk ManagementDesign Control SupportPeople ManagementEffective CommunicationAttention to DetailCritical ThinkingProblem SolvingOrganizational Skills

Qualifications

Bachelor's Degree in Scientific Field7+ Years Overall Experience5 Years Managerial Experience5 Years Human Tissue or Medical Device Manufacturing Experience

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Tuition Assistance

Full job description

Overview

Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Ability to travel up to 20% of time to MTF locations and to suppliers as required

Monday through Friday 8:15am to 4:30pm

Salary Range : $125,000/yr.

Responsibilities

Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance. Also performs active management and observations of staff for compliance with regulations and process efficiencies.
Assist in managing the budget for Regulatory Affairs department, including salaries, benefits, external vendors/consultants, supplies, services and internal expenses. Responsible for formulating/submitting budgets and managing to expense within budget requirements. Tracks monthly "budget to actual" performance.
Oversee and assist in the preparation, submission, and maintenance of U.S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets).
Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 certifications.
Participates in the development of regulatory strategies and pathway to support the regulatory designation of new products and tissues.
Serve as a primary regulatory contact during inspections and audits and lead regulatory intelligence activities.
Communicates and coordinates with VP and MTF senior management and other department heads on regulatory issues and regulatory strategies which may impact MTF's ability to fulfill its mission.
Communicates with federal/state regulatory agencies, international government and notified bodies, and AATB related to applicable new or revised regulations and standards
Assist on special projects and performs additional duties as assigned.

Qualifications

Bachelor's degree in a scientific or related field, or a combination of education and equivalent work experience
7+ Years of overall experience
5 Years of Managerial experience
5 Years or Human tissue or medical device manufacturing
Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma Must exhibit people management, effective communication skills
Attention to detail, critical thinking, problem-solving, and organizational skills
Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies
Ability to travel up to 20% of time to MTF locations and to suppliers as required